Kornimate/medical-research-clean huggingface dataset:
annual study to investigate inactivated subunit influenza vaccine due to new virus strains for the 2012/2013 season

Conditions: Prophylaxis of Influenza

Summary: annual study to investigate influenza vaccine (flu vaccine) developed for the 2012/2013 season for the prevention of influenza infection. the immunizing effect is being investigated, as well as its tolerability and safety.

an open, baseline-controlled study in two age groups: adults and elderly. the subjects will be screened within 14 days prior to or at visit 1 (day 1). at visit 1 (day 1) subjects will be vaccinated after blood sampling for baseline serum antihemagglutinin antibody titration. subjects will be asked to record local and systemic reactions daily on a diary at home for 72 hours after vaccination. one week later (visit 2, day 8) the subjects will return to the study site to hand in the diary and for the assessment of safety and tolerability (reactogenicity and overall inconvenience). three weeks after vaccination (visit 3, day 22) the subjects will return to the study site for blood sampling to assess immunogenicity and for the assessment of safety and tolerability.

Eligibility criteria:
inclusion criteria 1. willing and able to give informed consent and able to adhere to all protocol required study procedures. 2. men and women aged ≥ 18 and ≤ 60 years or ≥ 61 years of age at the day of study vaccination. 3. being in good health as judged by medical history, physical examination (if needed) and clinical judgment of the investigator. exclusion criteria 1. known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine. 2. a serious adverse reaction after a previous (influenza) vaccination. 3. presence of any significant condition that may prohibit inclusion as determined by the investigator. 4. seasonal or pandemic influenza vaccination or laboratory confirmed seasonal or pandemic influenza infection within the previous six months before study vaccination or planned vaccination during the study period. 5. having any condition which suppresses the immune system and autoimmune disorders.

Keywords: influenza vaccine chmp criteria
consistency of traditional chinese medicine diagnoses and herbal prescriptions for rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: practitioners of traditional chinese medicine (tcm) make diagnoses based solely on clinical symptoms. this study will evaluate whether tcm practitioners make diagnoses consistently.

tcm is one of the oldest and most widely-used indigenous medical systems in the world. it is difficult to effectively practice or evaluate tcm outside of its core framework, which includes a diagnostic system that is more conceptual and less technologically driven than that of conventional medicine. tcm diagnosis relies entirely on clinical symptoms and signs that are discerned by the practitioner. the establishment of diagnostic and prescriptive consistency is crucial for efficacy studies involving individualized treatments within the tcm framework. this study will examine the consistency of tcm diagnoses and herbal prescriptions under controlled conditions. rheumatoid arthritis (ra) patients will be individually evaluated by three tcm practitioners; the diagnostic and prescriptive behaviors of the practitioners will be recorded and analyzed to determine: 1) the extent to which two or more tcm practitioners assign comparable tcm diagnoses to the same ra patients; 2) the extent to which two or more tcm practitioners prescribe comparable herbal formulas to the same ra patients; and 3) the extent to which tcm diagnoses are related to conventional clinical assessments and biomedical tests of ra. variables that cause inconsistency will be identified and analyzed.

Eligibility criteria:
inclusion criteria * rheumatoid arthritis

Keywords: rheumatoid arthritis tcm diagnosis traditional chinese medicine complementary therapies
non-invasive home ventilation in patients with severe hypercapnic chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease; Hypercapnia

Summary: in copd patients with chronic hypercapnic respiratory failure, the prognosis is poor and the treatment with non invasive ventilation is actually well established. however the best mode of ventilation is not well known. in severe copd patients various disorders of respiratory mechanics result in insufficient ventilation, which can be life-threatening or create niv discomfort. the main characteristic of these disorders is a cyclical closing of small airways that can limit an expiratory flow and provoked some fluctuations in flow curve. to our knowledge, the management of dynamic hyperinflation seems to play an important role in explaining the effect of the niv. few studies have examined the effects of the machine's adjustments on dynamic hyperinflation. the main objective of this study is to analyze the impact of specific ventilatory modes supposed to reduce the dynamic hyperinflation on the hematosis, by studying transcutaneous pressure of carbon dioxide, in severe hypercapnic copd patients ventilated by niv. two modes of ventilation will be compared. first one is an algorithmic mode developed by the company löwenstein (airtrap control, trigger lockout and the expiratory pressure ramp). the second one is a standard algorithmic mode, used in the same ventilator. these two ventilatory modes will be evaluated in each patient, during two consecutive nights in current living conditions at home.


Eligibility criteria:
inclusion criteria: * diagnosis of copd using gold 2017 criterion * optimal medical treatment of copd, ie. inhaled steroids, long-acting β2-agonist, long-acting anticholinergic, according to gold 2017 guidelines. * at least one acute exacerbation of copd with hypercapnic respiratory failure * introduction of niv distant to acute exacerbation of copd with persisting hypercapnia (\> 7kpa) on arterial blood gas at rest. * niv equipment from the service provider "don du souffle (dds)". * patient able to give their consent exclusion criteria: * contraindication to niv (consensus conference of sfar-splf-srlf) * obstructive sleep apnea with apnea/hypopnea index \> to 20/h * bmi \> 35 kg/m2 * low compliance with niv treatment (\<3h per day) * acute exacerbation copd during inclusion or ph \<7.30 in routine blood gas arterial * severe heart failure (new york heart association stage iv/iv) * unstable angina * severe arrhythmias * severe renal insufficiency stage \> 4 * other conditions than copd resulting in hypercapnia * pregnancy * patient without health insurance * patient excluded by another study
colchicine and crp in atrial fibrillation and af ablation

Conditions: Atrial Fibrillation

Summary: colchicine will lower c-reactive protein (crp) in chronic atrial fibrillation and reduce the rise in crp which occurs following atrial fibrillation ablation

three groups of patients will be randomized to colchicine 0.6 mg po bis in die (bid) or matching placebo: 1. paroxysmal atrial fibrillation, pre-ablation 2. persistent atrial fibrillation, pre-ablation 3. chronic persistent atrial fibrillation

Eligibility criteria:
inclusion criteria: * group 1: persistent or chronic af presenting for evaluation in cardiology offices. diagnosis of af will be made based on the 12 -lead surface ecg. * group 2: paroxysmal af scheduled to go af ablation presenting to the electrophysiology laboratory for the procedure in sinus rhythm.. * group 3:chronic af scheduled to go clinically indicated af ablation, and presenting in the electrophysiology laboratory in atrial fibrillation . exclusion criteria: 1. abnormal liver function with elevated enzymes\> 1.5 times the normal. 2. abnormal kidney function with glomerular filtration rate \< 50 ml/min 3. increased levels of creatine kinase or known myopathy 4. neutropenia 5. known gi disorders 6. women of childbearing age who have not had surgical sterilization and are not using oral contraceptives, or who's spouse has not had surgical sterilization will be excluded due to the length of the trial and the possibility that they could become pregnant after entry. 7. pregnant and lactating women 8. lactose intolerance 9. known sensitivity, allergy, or contraindication to colchicine use

Keywords: atrial fibrillation catheter ablation colchicine c reactive protein crp
effects of dead bug vs. mc gill exercises on pain, qol and core stability in patient with chronic nonspecific lbp

Conditions: Low Back Pain

Summary: low back pain is one of the most common conditions for which patients are sent to physiotherapy clinics. 84% of people have experienced it at least once in their lifetime, and over 50% have experienced it more than once, according to research. however, diagnosis and, in particular, the provision of specialized back pain therapy remain difficult.

this study aims to compare the effects of dead bug vs. mc gill exercises on pain, quality of life and core stability in patient with chronic nonspecific low back pain. it will be a randomized clinical trial study. the sample size of study will be 44 participants (22 in each group). data will be collected from azra naheed hospital. data will be collected within 6 months after approval of synopsis. group a will follow dead bug exercises and group b will follow mc gill exercises (curl up, side bridge and bird dog). the patients in both groups will be performed the corresponding exercises 3 days a week and 10 repetitions of each exercise for a period of 6 weeks and a rest interval of 2 minutes between exercises. the exercises will be taught to the patients at the end of the first session in both groups. the data will be analyzed using spss version 24 for windows software. statistical significance will be set at p ≤ 0.05. normality of data will be assessed through kolmogorov-smirnov test. difference between pre-treatment and post-treatment readings will be calculated using paired sample t-test for parametric data. for non-parametric data wilcoxon test will be used. independent sample t test will be used for parametric data and mann whitney test will be used for non parametric data.

Eligibility criteria:
inclusion criteria: * age 30-50 years * patient with the history of 3 months nonspecific low back pain * pain intensity (3-7) according to vas score exclusion criteria: * spinal stenosis * neurological dysfunction * systemic disease * pregnancy * infections * carcinoma * any fracture or deformity
the evaluation for fu's subcutaneous needling (fsn) in carpal tunnel syndrome.

Conditions: Carpal Tunnel Syndrome

Summary: the goal of this clinical trial is to evaluate the efficacy of fu's subcutaneous needling (fsn) in carpal tunnel syndrome (cts). the main questions it aims to answer are: * dose fsn improve the symptoms of cts? * dose fsn decrease cross section area of median nerve in cts patients? * dose fsn have the effect of electrophysiology exam in cts patients? participants will receive wrist splinting and fsn treatment respectively. researchers will compare wrist splinting group with fsn group to see if fsn being effective for cts.


Eligibility criteria:
inclusion criteria: 1. male or female aged 20-85 years old. 2. meet the diagnosis of mild to moderate carpal tunnel syndrome. 3. if the patient has carpal tunnel syndrome in both hands, choose the side with mild or moderate carpal tunnel syndrome. 4. after being explained, join the trial voluntarily and sign the subject's consent form. exclusion criteria: 1. caused by trauma or mass lesion. 2. thenar muscle atrophy. 3. electrophysiological examination revealed severe cts. 4. chronic kidney disease, rheumatoid arthritis, abnormal thyroid function, diabetes. 5. psychiatric history or incapable of cooperating with the investigator. 6. pregnancy. 7. history of substance abuse or long-term steroid use. 8. history of median nerve surgery. 9. those who do not sign the consent form.

Keywords: fu's subcutaneous needling, carpal tunnel syndrome
glycemic variability: prognostic impact on acute ischemic stroke

Conditions: Brain Ischemia; Hyperglycemia; Glycemic Variability

Summary: this is a multicenter observational clinical study in patients with acute ischemic stroke. the main objective is to evaluate the impact of glycemic variability (gv) on stroke outcome (mortality, functional recovery) of patients with acute ischemic stroke. glycemic variability will be assessed using a subcutaneous device for continuous glycaemia motorization during 96 hours; also capillar glycaemia will be measured every 6 hours.

10 different hospitals in spain will participate in this study, recruiting a total of 340 patients. once the informed consent form is signed, the subcutaneous device for continuous glycaemia motorization will be implanted and demographic, comorbidities and treatments of every patient will be registered. during the first 96 hours, capillar glycaemia, nihss scale, hba1c levels, cerebral recanalization treatment and glycaemia correcting treatments will also be reported. in the following days (7, 30 and 90 days after stroke) modified rankin scale, nihss scale and stroke secondary prevention treatments will be evaluated. at day 90, a new measure of hba1c will be done.

Eligibility criteria:
inclusion criteria: * \> 18 years old * inclusion less than 24 hours from ischemic stroke * functional independence prior to stroke * signed informed consent exclusion criteria: * transient cerebral ischemia * prevision of need to perform a magnetic resonance within the first 96 hours from inclusion * concomitant severe or deadly disease that may interfere with study follow-up during 3 months from stroke * current drug or alcohol abuse that may interfere with study follow-up * participation in a clinical trial
effects of a computerized working memory training program on attention, working memory, and academics, in adolescents with severe adhd/ld

Conditions: Attention Deficit Disorder With Hyperactivity; Learning Disorders

Summary: our primary aim is to determine whether a computerized working memory (wm) training program will help students with severe learning and attention problems, in terms of improving their wm. additional aims are to determine whether the wm training will also result in improvements in the students' concentration and school work, and how long any beneficial effects will last (i.e., whether the students will continue to show improvements once the training program has stopped).

we have established a collaborative partnership between oise, hsc, opds, and jvs to evaluate the effectiveness of a wm training program when conducted in a school setting. to determine whether the wm training program does improve wm, attention, behaviour, and/or academic achievement, we will compare its effects to those expected to result from two other intervention programs that focus on academic skills only: 1) a computerized software program known to improve math skills (academy of math®); and 2) extra, individualized tutoring in an area of academic weakness supervised by a trained and experienced staff person. we will assess wm, related cognitive abilities, adhd symptoms, academic achievement, before and after intervention, and also at 3- and 6-month follow-up to determine whether any improvements are sustained and increased after the training has finished.

Eligibility criteria:
inclusion criteria: * fulltime enrollment at one of the three english-language speaking opds schools * confirmed diagnosis of a specific ld with or without comorbid adhd * iq \> 80 (based on wisc-iv) * english as the primary spoken language exclusion criteria: * uncorrected sensory impairments (vision, hearing) * severe comorbid mental health disorders requiring medications other than those used for adhd or intensive treatment * severe impairments in oral communication, impeding intelligibility of spoken responses

Keywords: pediatrics attention-deficit hyperactivity disorder learning disorder computerized working memory training program
tvns for cognitive impairments in community-dwelling elderly

Conditions: Aging

Summary: the goal of this study is to explore the effects of transcutaneous vagus nerve stimulation(tvns) on improving cognition in community-dwelling elderly people. the study will recruit 120 subjects. participants will undergo baseline cognitive assessment, eeg and eye tracking. participants will be randomized to tvns group and sham group. all subjects will repeat the baseline assessments after 1st session, 5th session，10th session and within 3 days after 10th session.

transcutaneous vagal nerve stimulation (tvns) is a non-invasive neurostimulation technology.recent studies have found that tvns may involve in the regulation of cognition and improve the memory of the elderly.however, due to the limited number of studies, the effect of tvns on improving cognitive function and stimulation parameters are currently unclear. to investigate the effects of tvns on improving cognition in community-dwelling elderly people, our study will recruit 120 subjects. participants will undergo baseline cognitive assessment, eeg and eye tracking. active vs. sham treatment will be randomly assigned in a 1:1 fashion in groups using computer generated lists. subjects and evaluators will be blind to treatment. all subjects will repeat the baseline assessments after 1st session, 5th session，10th session and within 3 days after 10th session.

Eligibility criteria:
inclusion criteria: (1) 65≤age≤75 years old; (2) years of education ≥1 year; (3) normal daily life ability; (4) total score of the chinese version of mini-mental state examination (mmse) : non-illiterate group (not graduated from elementary school)\> 14 points, elementary school group\> 19 points, middle school and above group\> 24 points). exclusion criteria: (1) people with obvious hearing, vision problems or communication difficulties; (2) people with obvious cognitive dysfunction (such as alzheimer's disease); (3) people with serious medical diseases (such as heart disease, uremia, severe diarrhea) ; (4) in the stage of radiotherapy and chemotherapy; (5) people with serious neurological diseases (such as parkinson's disease, infectious encephalopathy); (6) patients with mental diseases (such as schizophrenia, depression, etc.); 7) patients with substance abuse or alcohol dependence; (8) patients with implantable medical devices such as cardiac pacemakers; (9) patients with scars or inflammation on the ear skin.

Keywords: transcutaneous vagal nerve stimulation (tvns) aging cognition
effects of core stabilization exercises versus foot-ankle strengthening program in patients with knee osteoarthritis.

Conditions: Knee Osteoarthritis (OA)

Summary: knee osteoarthritis (oa) is also known as degenerative joint disease, is typically the result of wear and tear and progressive loss of articular cartilage. it is most common in the elder population. it results from functional disability and altered knee biomechanics. risk factors of knee oa include; older age, genetics and obesity, female gender. the aim of this study is to compare the effects of core stabilization exercises versus foot-ankle strengthening program on pain, physical function and quality of life in patients with knee osteoarthritis.

a randomized clinical trial will be conducted at riphah physiotherapy clinic lahore, fmh physiotherapy department, hamza hospital physiotherapy clinic, lahore through convenient purposive sampling technique 46 patients which will be allocated by using simple randomization through computer generated software into group a and group b. group a will be treated with core stabilization exercises and ankle-foot strengthening program and group b will be treated with ankle-foot strengthening program at the frequency of 3 sets with 10 repetitions thrice per week in the total duration of 6 weeks. outcome measures will be conducted through (nprs), (womac), knee osteoarthritis outcome score (koos) questionnaire and quality of life (sf-36) questionnaire before and after 6 weeks. data will be analyzed using spss software version 25. after assessing normality of data by shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.

Eligibility criteria:
inclusion criteria: * both genders of 40-65 years of age will include in this study. * knee oa of grade 1-2. * individuals with significant unilateral and bilateral knee osteoarthritis. symptoms and positive radio-graphical findings. * difficulty in walking/stair climbing. exclusion criteria: * any history of knee fracture/ tumor/ infection and hip/knee surgery. * total knee replacement patients. * neurological disease. * patient received physical therapy treatment from last 6 months. * inflammatory arthritis (rheumatoid arthritis) * use of any intra-articular injections (steroid/ hyaluronic acid/ prp.) from last 3-6 months.

Keywords: knee osteoarthritis pain physical function quality of life
a patient navigation program to increase access to early supportive care in patients with stage iv solid tumors

Conditions: Neoplasm Metastasis

Summary: in this randomized clinical trial, patients with stage iv solid tumors will be enrolled in a patient navigator-led generalist palliative and supportive care intervention or in usual care led by their treating physician. the patient navigator will assess the patient's palliative and supportive care needs using standardized quality of life and symptoms questionnaires and present this assessment to a multidisciplinary team composed of oncologists and palliative care specialist. the multidisciplinary team will develop a personalized supportive care plan for the patient which will then be presented and discussed by the patient navigator. those interventions which are accepted by the patient will be implemented by the patient navigator, who will also provide education and teaching. the patient navigator will also help eligible patients complete advanced directives according to local rules and regulations. the patient navigator will follow the patients both in person and by telephone to ensure that the recommended interventions have been implemented. three months after enrollment the patients will undergo quality of life and symptom assessment once again, and the implementation of interventions will be recorded.


Eligibility criteria:
inclusion criteria: 1. male or female patients 18 years of age and older 2. newly diagnosed stage iv solid tumor 3. recurrent stage iv solid tumor exclusion criteria: 1. homeless persons 2. history of drug abuse or alcoholism 3. patients suffering from major psychotic disorders or uncontrolled psychiatric disorders 4. mentally disabled patients 5. incarcerated patients
the impact of pharmacist-led mobile application on adherence in chronic kidney disease patients

Conditions: Chronic Kidney Diseases; Adherence, Medication

Summary: the aim of the study is to assess the impact of pharmacist led mobile application on adherence and efficacy of medication in chronic kidney disease patients

this is a prospective randomized two group pharmacist-led interventional study that will be conducted in a private nephrology clinic. the study will involve introduction of the mobile phone applications to chronic kidney disease patients to improve their adherence to the prescribed medications. recruited patients will be randomly divided in two groups; intervention group and control group, with baseline evaluation of outcomes to be measured. control group will be provided with usual care. intervention group will be provided in addition to the usual care, with an access to the mobile application after a simple training for app usage. both groups will be followed for a period of 3 months. the study will include the development, validation and the testing for evaluating the specially designed mobile application.

Eligibility criteria:
inclusion criteria: * stages 2-5 of chronic kidney disease * literate * ownership of android smart phone compatible with the application * poly-pharmacy exclusion criteria: * on dialysis due to loss of kidney function * pregnancy due to altered physiology